Annals of Surgical Oncology

, Volume 17, Issue 4, pp 959–966 | Cite as

Long-Term Survival Results of Surgery Alone Versus Surgery Plus 5-Fluorouracil and Leucovorin for Stage II and Stage III Colon Cancer: Pooled Analysis of NSABP C-01 Through C-05. A Baseline from Which to Compare Modern Adjuvant Trials

  • Neal W. Wilkinson
  • Greg Yothers
  • Samia Lopa
  • Joseph P. Costantino
  • Nicholas J. Petrelli
  • Norman Wolmark
Colorectal Cancer



The objective of this study is to conduct a pooled analysis of National Surgical Adjuvant Breast and Bowel Project (NSABP) colon trials involving surgery and surgery plus 5-fluorouracil and leucovorin (5-FU/LV) to compare survival and establish a baseline from which to evaluate future studies.


All patients enrolled in NSABP adjuvant trials C-01 through C-05 with stage II and III disease who were treated with surgery or with surgery plus 5-FU/LV were examined for overall survival (OS), disease-free survival (DFS), and recurrence-free interval (RFI). Time-to-event by treatment group was examined using adjusted Kaplan–Meier estimates and multivariable Cox regression analysis.


There were 2,966 eligible patients: 693 (23%) surgery and 2,273 (77%) surgery plus 5-FU/LV; 1,255 (42%) stage II and 1,711 (58%) stage III. Age ≥60 years [hazard ratio (HR) = 1.36, P < 0.0001], male gender (HR = 1.20, P = 0.0012), and more nodes positive or fewer nodes examined (P < 0.0001) were associated with worse survival. At 5 years, the adjusted OS was 0.62 [confidence interval (CI) = 0.60–0.63] in the surgery group and 0.76 (CI = 0.74–0.78) in the surgery plus 5-FU/LV group. Treatment with 5-FU/LV was associated with improved outcome compared with surgery: OS (HR = 0.62, P < 0.0001), DFS (HR = 0.66, P < 0.0001) and RFI (HR = 0.64, P < 0.0001). Improved OS with adjuvant treatment was seen in both stage II (HR = 0.58, 95% CI = 0.48–0.71) and stage III disease (HR = 0.65, 95% CI = 0.55–0.75).


This analysis demonstrates that treatment of colon cancer patients with 5-FU/LV following surgery provides benefit over surgery alone and can provide anticipated survival outcomes with which to compare modern adjuvant trials.


Overall Survival Colon Cancer Colon Cancer Patient Adjuvant Trial Colon Cancer Surgery 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



These studies were supported by: Public Health Service grants U10-CA-12027, U10-CA-69651, U10-CA-37377, and U10-CA-69974, from the National Cancer Institute, Department of Health and Human Services.


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Copyright information

© Society of Surgical Oncology 2010

Authors and Affiliations

  • Neal W. Wilkinson
    • 1
    • 2
  • Greg Yothers
    • 1
    • 3
    • 4
  • Samia Lopa
    • 1
    • 3
    • 4
  • Joseph P. Costantino
    • 1
    • 3
    • 4
  • Nicholas J. Petrelli
    • 1
    • 5
  • Norman Wolmark
    • 1
    • 6
  1. 1.National Surgical Adjuvant Breast and Bowel Project (NSABP)PittsburghUSA
  2. 2.Division of Surgical OncologyUniversity of IowaIowa CityUSA
  3. 3.NSABP Biostatistical CenterPittsburghUSA
  4. 4.Department of BiostatisticsThe University of Pittsburgh Graduate School of Public HealthPittsburghUSA
  5. 5.Helen F Graham Cancer Center NewarkNewarkUSA
  6. 6.Allegheny General HospitalPittsburghUSA

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